QA Manager - Inspection Management

Randstad Professionals is actively seeking a Senior Quality Manager for their client in Basel. As a Quality Manager you support inspections as part of the compliance support group including the Drug Product Manufacturing.

Your responsibilities include

Primarily:

- Main Responsibility for planning, coordination of self-inspections in Basel and Kaiseraugst
- Performing self-inspections at Drug Product Manufacturing Basel
- Responsibility for own implementation, documentation and tracking of self-inspections
- Co-ordination, documentation and tracking of health authority and customer inspections
- Ensuring the readiness inspection at the site regarding regulatory requirements

General Tasks:

- Provide Production and Quality departments input to the review and approval of manufacturing and Quality related documents
- Review of GMP documents as requested
- Review current health authority observations and warning letters to monitor the inspection climate.
- Participate in post-inspection activities including observation response process and commitment follow-up and tracking
- Implement Inspection Readiness procedures and ensure inspection readiness for Kaiseraugst and Basel parenterals production
- Conduct Inspection Readiness" training for managers, groups and SMEs
- Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance

Job Profile:

- University degree in pharmacy, microbiology, chemistry or biochemistry or a similar training (eg, Quality Engineer)
- Several years of professional experience in the pharmaceutical parenterals production and/or quality assurance and/or Quality Management
- Sound knowledge of international GMP experience
- In-depth knowledge of FDA specific regulatory requirements
- In-depth knowledge in Inspection Readiness Procedures
- In-depth Auditing experience
- Team player and a communicative personality
- Assertiveness and initiative is a must
- Thorough and independent way of working
- In-depth knowledge of documentation systems and computer skills.
- Very good oral and written English skills